OBJECTIVES : Disease rating scales used in AD are essential tools for diagnosis, staging, assessment and monitoring of AD symptoms, as well as for the efficacy evaluation of treatments. Multiple scales have been employed to assess patients’ cognition, daily functions, behavioral symptoms, and quality of life. This analysis was conducted to identify the scales used in RCTs in product labels of approved AD treatments.

METHODS : Labels of donepezil, rivastigmine, galantamine, and memantine approved by the US FDA, European Medicines Agency, Health Canada, and TGA Australia were searched to identify the RCTs and reviewed for the scales used.

RESULTS : A total of 28 unique RCTs were identified, which had patients with mild-to-moderate AD (n=16), moderate-to-severe AD (n=8) and severe AD (n=4). Identified RCTs were for donepezil (n=11), galantamine (n=6), rivastigmine (n=6) and memantine (n=5). Duration of RCTs of mild-to-moderate and moderate-to-severe AD was mostly from 24-weeks to 1-year, and sample size was 209 to 1584 patients. RCTs conducted in severe AD were in duration from 12- to 24-weeks, and sample size was 166 to 343 patients. Mini-Mental State Examination (MMSE; n=24) score was often assessed at baseline to define AD stages, followed by Global Deterioration Scale (n=4), Clinical Dementia Rating Scale (CDR; n=3) and Functional Assessment Staging (n=3). The Clinician’s Interview-Based Impression of Change (CIBIC)-plus (n=18) and Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL; n=11) were assessed as the endpoints in ≥1 RCTs of all four products, while Alzheimer’s Disease Assessment Scale for cognition (ADAS-Cog; n=14) and Severe Impairment Battery (SIB; n=10 RCTs) were evaluated in ≥1 RCTs of three products.

CONCLUSIONS : This analysis suggested that MMSE is the most commonly used screening criteria to define the AD stages. CIBIC-plus and ADAS-Cog are the most frequently assessed outcomes in RCTs with mild-to-moderate AD patients, while ADCS-ADL and SIB in moderate-to-severe AD patients.